Contrast-induced NephropathyNCT05271448
Continuing or Discontinuing ACE/ARBs in Patients With Chronic Kidney Disease Undergoing Coronary Angiography
A study testing Continue ACEI or ARBs ( Enalapril , Ramipril , Valsartan , Candesartan, Losartan ) and Hold ACEI or ARBs in people with Contrast-induced Nephropathy and Chronic Kidney Diseases, run by An-Najah National University at 1 site in Palestinian Territories.
Trial summary
Contrast induced nephropathy (CIN) is a well-known possible complication of percutaneous coronary intervention (PCI) with an incidence varies from 3.3% to 14.5% in patients undergoing PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast-induced Nephropathy, Chronic Kidney Diseases, Ischemic Heart Disease
- What is being tested?
- Continue ACEI or ARBs ( Enalapril , Ramipril , Valsartan , Candesartan, Losartan ) and Hold ACEI or ARBs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 1 Jun 2021to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least one month of continuous therapy with an ACEI or an ARBs and
- Undergoing elective coronary angiography and
- Have CKD stage3-4 (15≤GFR<60 ml/min/1.73 m2).
Who cannot join
- Acute STEMI within 2 weeks
- NYHA class IV heart failure by history
- Administration of contrast load within the previous 6 days
- acute renal failure (ARF) preceding coronary angiography
- potassium level more than 5.0 meq/l
- GFR <15 ml/min/1.73 m2
Show all 15Show fewer
- previous percutaneous cardiac catheterization within one month
- Acute pulmonary edema
- hemodynamically instability
- uncontrolled hypertension
- combination ACEI and ARB therapy
- Cardiogenic shock
- Sepsis
- pregnancy
- Age below 18 year
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site, 1 recruiting
- Recruiting
An-Najah National University Hospital
Nablus, West Bank, P4170051
Yunis A Daralammouri, asst. prof, +972598434614, yunis71@yahoo.de
Murad M Azamtta, MD, +972595762566, m.azamttah@gmail.com
About this study
Official title: The Effect of Continuing or Discontinuing ACE-I/ARBs Therapy on the Incidence of Contrast-induced Nephropathy in Patients With Chronic Kidney Disease Undergoing Coronary Angiography; a Randomized Controlled Trial
Contrast induced nephropathy (CIN) is a well-known possible complication of percutaneous coronary intervention (PCI) with an incidence varies from 3.3% to 14.5% in patients undergoing PCI.
Many previous randomized and non-randomized studies have shown very conflicting results regarding the use of ACE-Is prior to coronary angiography, and whether it decreases or increases the risk of CIN. The importance of this study is to help find an acceptable and reliable answer for the use of ACE-I/ARBs prior to cardiac catheterization.
This research aims to study the effect of withholding ACE-Is or ARBs on the incidence of contrast induced nephropathy in patients undergoing coronary angiography who have chronic kidney disease (GFR<60 ml/min/1.73 m2) and to help build evidence-based data and guidelines on the safety of continuing or withholding ACE-I/ARBs pre contrast administration.
Read the detailed description
The study design is a Randomized Control Trial; it will be done on two groups of patients. The two groups are group A (continue ACE-I/ARBs) and group B (withhold ACE-I/ARBs).
The study will be conducted at the cardiology units at An-Najah National University's hospital (NNUH) in Nablus, Palestine.
Study population includes chronic kidney disease patients taking ACE-I or ARBs therapy and are undergoing elective coronary angiography.
Patients who will meet the inclusion criteria and have none of the exclusion criteria will be enrolled in the trial when the appointment of their procedure is set.
They will be randomly divided into two groups; group A (continue ACE-I or ARBs therapy) and group B (withhold ACE-I or ARBs therapy)using block randomization, each block consists of four participants.
Patients in the continuation group will take their regular ACE-I/ARBs on the day of the angiogram. Patients in the discontinuation group will be withheld from their ACEI or ARBs 24 h before cardiac catheterization.
- Being tested
- Continue ACEI or ARBs ( Enalapril , Ramipril , Valsartan , Candesartan, Losartan ), Hold ACEI or ARBs
- Keywords
- Cardiac catherization, coronary angiography, Coronary angioplasty, chronic kidney disease, contrast induced nephropathy, ACEI, ARBs
- Medical subject headings
- Renal Insufficiency, Chronic, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continue ACEI or ARBs ( Enalapril , Ramipril , Valsartan , Candesartan, Losartan )Other
Also called Continue ACEI or ARBs
Randomized to continue on prescribed ACE1 or ARBs ( Enalapril 5, 10, 20 mg // Ramipril 2.5 , 5 mg // Valsartan 80 , 160 mg // Candesartan 8, 16 mg // Losartan 50 mg )
Hold ACEI or ARBsOther
Angiotensin converting enzyme inhibitor or angiotensin receptor blocker held at least 24 hours pre-cardiac catheterization and restarted 48-72 hours post-catheterization (after creatinine measurement)
Other Name: Includes all ACEI inhibitors or ARBs
| Study group | Role | What they receive |
|---|---|---|
| Continue ACEI or ARBs | Experimental | Randomized to continue on prescribed ACE1 or ARBs Receives: Other: Continue ACEI or ARBs ( Enalapril , Ramipril , Valsartan , Candesartan, Losartan ) |
| Hold ACEI or ARBs | Active comparator | Angiotensin converting enzyme inhibitor or angiotensin receptor blocker held >= 24 hours pre-cardiac catheterization and restarted post-catheterization after creatinine measurement (48-72 hours post) Receives: Other: Hold ACEI or ARBs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Contrast induced nephropathy
Contrast induced nephropathy (creatinine rise of ≥0.5 mg/dL or a relative increase ≥25%compared to the pre-randomization creatinine level) at 48-72hrs
Measured: 48 - 72 hours post-cardiac catheterization
Secondary outcomes (4)
Serum creatinine level
Change in serum creatinine at 48-72hrs
Measured: 48 - 72 hours post-cardiac catheterization
Number of Participants with Hyperkalemia
Serum potassium increased to > 5.5 mg/dL at 48-72hrs
Measured: 48 - 72 hours post-cardiac catheterization
Creatinine clearance
Change in Creatinine clearance at 48-72hrs
Measured: 48 - 72 hours post-cardiac catheterization
Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-72hrs
Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-72hrs
Measured: 48 - 72 hours post-cardiac catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start1 Jun 2021
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast-induced NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- An-Najah National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunis Daralammouri, An-Najah National University
- Investigators
- Yunis A Daralammouri, asst. prof., Principal investigator, An-Najah National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271448
- Sponsor's protocol ID
- ACEI/ARBs/CKD/CATH
- Status last verified
- Jun 2023
- First submitted
- 15 Jan 2022
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuing or Discontinuing ACE-I/ARBs Therapy on the Incidence of Contrast-induced Nephropathy in Patients With Chronic Kidney Disease Undergoing Coronary Angiography; a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05271448
- Acronym / sponsor ID
- ACEI/ARBs/CKD/CATH
- Keywords
- Cardiac catherization, coronary angiography, Coronary angioplasty, chronic kidney disease, contrast induced nephropathy, ACEI, ARBs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- An-Najah National UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Contrast induced nephropathy (CIN) is a well-known possible complication of percutaneous coronary intervention (PCI) with an incidence varies from 3.3% to 14.5% in patients undergoing PCI.
Many previous randomized and non-randomized studies have shown very conflicting results regarding the use of ACE-Is prior to coronary angiography, and whether it decreases or increases the risk of CIN. The importance of this study is to help find an acceptable and reliable answer for the use of ACE-I/ARBs prior to cardiac catheterization.
This research aims to study the effect of withholding ACE-Is or ARBs on the incidence of contrast induced nephropathy in patients undergoing coronary angiography who have chronic kidney disease (GFR<60 ml/min/1.73 m2) and to help build evidence-based data and guidelines on the safety of continuing or withholding ACE-I/ARBs pre contrast administration.
Detailed description
The study design is a Randomized Control Trial; it will be done on two groups of patients. The two groups are group A (continue ACE-I/ARBs) and group B (withhold ACE-I/ARBs).
The study will be conducted at the cardiology units at An-Najah National University's hospital (NNUH) in Nablus, Palestine.
Study population includes chronic kidney disease patients taking ACE-I or ARBs therapy and are undergoing elective coronary angiography.
Patients who will meet the inclusion criteria and have none of the exclusion criteria will be enrolled in the trial when the appointment of their procedure is set.
They will be randomly divided into two groups; group A (continue ACE-I or ARBs therapy) and group B (withhold ACE-I or ARBs therapy)using block randomization, each block consists of four participants.
Patients in the continuation group will take their regular ACE-I/ARBs on the day of the angiogram. Patients in the discontinuation group will be withheld from their ACEI or ARBs 24 h before cardiac catheterization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continue ACEI or ARBs | Experimental | Other: Continue ACEI or ARBs ( Enalapril , Ramipril , Valsartan , Candesartan, Losartan )Randomized to continue on prescribed ACE1 or ARBs |
| Hold ACEI or ARBs | Active comparator | Other: Hold ACEI or ARBsAngiotensin converting enzyme inhibitor or angiotensin receptor blocker held >= 24 hours pre-cardiac catheterization and restarted post-catheterization after creatinine measurement (48-72 hours post) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least one month of continuous therapy with an ACEI or an ARBs and
- Undergoing elective coronary angiography and
- Have CKD stage3-4 (15≤GFR<60 ml/min/1.73 m2).
Key exclusion criteria (15 listed)
- Acute STEMI within 2 weeks
- NYHA class IV heart failure by history
- Administration of contrast load within the previous 6 days
- acute renal failure (ARF) preceding coronary angiography
- potassium level more than 5.0 meq/l
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continue ACEI or ARBs ( Enalapril , Ramipril , Valsartan , Candesartan, Losartan )Also: Continue ACEI or ARBsRandomized to continue on prescribed ACE1 or ARBs ( Enalapril 5, 10, 20 mg // Ramipril 2.5 , 5 mg // Valsartan 80 , 160 mg // Candesartan 8, 16 mg // Losartan 50 mg ) | Other | Continue ACEI or ARBs |
| Hold ACEI or ARBsAngiotensin converting enzyme inhibitor or angiotensin receptor blocker held at least 24 hours pre-cardiac catheterization and restarted 48-72 hours post-catheterization (after creatinine measurement) Other Name: Includes all ACEI inhibitors or ARBs | Other | Hold ACEI or ARBs |
Primary outcome
Number of Participants with Contrast induced nephropathy
Time frame: 48 - 72 hours post-cardiac catheterization
Contrast induced nephropathy (creatinine rise of ≥0.5 mg/dL or a relative increase ≥25%compared to the pre-randomization creatinine level) at 48-72hrs
4 secondary outcomes
Serum creatinine level
Time frame: 48 - 72 hours post-cardiac catheterization
Number of Participants with Hyperkalemia
Time frame: 48 - 72 hours post-cardiac catheterization
Creatinine clearance
Time frame: 48 - 72 hours post-cardiac catheterization
Death, Myocardial Infarction, Stroke, Congestive Heart Failure, dialysis, major bleeding, minor bleeding, hypertension, re-hospitalization at 48-72hrs
Time frame: 48 - 72 hours post-cardiac catheterization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
Related trials for Contrast-induced Nephropathy
Recruiting
Effectiveness of Remote Ischemic Preconditioning for Prevention of Contrast Induced Acute Kidney Injury in Patients Undergoing Coronary Angiograms.
Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
Not yet recruitingObservational study
Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures
Contrast-Induced Nephropathy, Acute Kidney Injury
Not yet recruitingObservational study
An Observational Study of Percutaneous Glomerular Filtration Rate (TGFR) in the Early Warning of Contrast-induced Acute Kidney Injury During the Peri-examination Period of Emergency Enhanced CT
Contrast-associated Acute Kidney Injury
Not yet recruitingObservational study
Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN)
Not yet recruitingObservational study
Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
Contrast-Associated Acute Kidney Injury, Acute Kidney Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunis A Daralammouri, asst. prof. principal investigator
An-Najah National University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continue ACEI or ARBs ( Enalapril , Ramipril , Valsartan , Candesartan, Losartan ) and Hold ACEI or ARBs in people with Contrast-induced Nephropathy and Chronic Kidney Diseases, run by An-Najah National University at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yunis A Daralammouri, asst. prof. (+970598434614, yunis71@yahoo.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Contrast induced nephropathy (time frame: 48 - 72 hours post-cardiac catheterization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.